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A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy (FOLIC)

Primary Purpose

Cerebral Palsy, Muscle Disorder, Physical Disability

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Loaded high intensity training
High intensity circuit training (HICT)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: have a confirmed diagnosis of spastic cerebral palsy independent ambulatory able to follow verbal instructions willing to commit to participate for the full study Exclusion Criteria: had previous orthopedic surgery or botulinum toxin A injection in the lower limb within past 6 months had a structured lower limb exercise training within the past 6 months plan to go for any structured outside-of the-study exercise training had any heart, lung, vision, hearing or bodily issues that can interfere with participation and completion of the study had any other diseases that interfere with physical activity.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Loaded high intensity circuit training

High Intensity Training

Control

Arm Description

These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 2-5 of the intervention, the participants will perform the exercises with an adjustable weight vest starting with 2.5% to finally reaching 10% of their body weight.

These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.

They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.

Outcomes

Primary Outcome Measures

Physical Activity
Step counts.
Physical Activity
Step counts. An increase in step counts is expected.

Secondary Outcome Measures

Muscle Stiffness
Measure muscle and tendon stiffness. A decrease in stiffness is expected.
Muscle Stiffness
Measure muscle and tendon stiffness. A decrease in stiffness is expected.
Four square step test
Measure by time to complete test. A decrease in time completed is expected.
Four square step test
Measure by time to complete test. A decrease in time completed is expected.
Jumping test
Measure by jump height. An increase in jump height is expected.
Jumping test
Measure by jump height. An increase in jump height is expected.

Full Information

First Posted
May 1, 2023
Last Updated
August 15, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05865418
Brief Title
A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy
Acronym
FOLIC
Official Title
Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy.
Detailed Description
Only 25% of independent ambulatory children with spastic cerebral palsy (CP) meet the recommendations of time spent in physical activity (PA). Lack of PA during growing years is one of the root causes of obesity, diabetes, and hypertension. Children with CP are known to have poorer dynamic balance and weaker muscle strength than typically developing children, explaining their slower walking speeds, lower PA, and higher tripping and falling than typically developing children. These deficits markedly amplify in adolescence. Consequently, there is a critical need to mitigate deficits in muscle strength and dynamic balance in ambulatory adolescents with CP to increase PA. High intensity circuit training (HICT) vs progressive resistance training (PRT) improved PA to a greater degree in children with CP. Despite the use of HICT, PA in children with CP is still below the recommended level. Our new exercise protocol combines the principles of HICT and PRT in one training program to improve PA in adolescences with CP. The aim of this study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy. In order to test the feasibility and response of the new exercise protocol, this study will have 3 groups of participants: 1) functionally loaded high intensity training exercise group, 2) a high intensity circuit training group, and 3) control group. For those two exercise groups, this study will include 4-week (weeks 2 - 5) exercise training program (including chair squat, side-step, split squat, heel raise, and jump). Children may/may not wear a weighted vest during exercising depend on their assigned group. For the non-exercise/control group, there is no intervention. Each group will have 2 sessions of baseline testing in week 1 and 1 session of post-testing in week 6. Coming for a single session of testing in week 9 is optional. The following tests will be assessed before and after the exercise training program for all the groups: Lower limb strength and power via jump tests, balance via four-square step test, lateral step-up test, timed up and go tests, and walking tests. Their muscle and tendon stiffness will be assessed via a handheld device. Free living PA will be assessed via waist-worn accelerometers and questionnaires. Testing will be performed at 5 time points: tests at the first week (baseline 1 and baseline 2), sixth week (post training), ninth week (the follow up) of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Muscle Disorder, Physical Disability, Posture Disorders in Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be blinded to the group assignment.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Loaded high intensity circuit training
Arm Type
Experimental
Arm Description
These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 2-5 of the intervention, the participants will perform the exercises with an adjustable weight vest starting with 2.5% to finally reaching 10% of their body weight.
Arm Title
High Intensity Training
Arm Type
Active Comparator
Arm Description
These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Loaded high intensity training
Intervention Description
Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 3rd of the intervention, the participants will perform the exercises with an adjustable weight vest with 5% of their body weight. In the middle intervention (post week 6 of the intervention which will be week 9 of the study), adolescents will be reevaluated for all the measures tested at the baseline. Weight vest will increase to 10% of their body weight for the last 4 weeks of the intervention.
Intervention Type
Other
Intervention Name(s)
High intensity circuit training (HICT)
Intervention Description
Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.
Primary Outcome Measure Information:
Title
Physical Activity
Description
Step counts.
Time Frame
Week 1
Title
Physical Activity
Description
Step counts. An increase in step counts is expected.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Muscle Stiffness
Description
Measure muscle and tendon stiffness. A decrease in stiffness is expected.
Time Frame
Week 1
Title
Muscle Stiffness
Description
Measure muscle and tendon stiffness. A decrease in stiffness is expected.
Time Frame
Week 6
Title
Four square step test
Description
Measure by time to complete test. A decrease in time completed is expected.
Time Frame
Week 1
Title
Four square step test
Description
Measure by time to complete test. A decrease in time completed is expected.
Time Frame
Week 6
Title
Jumping test
Description
Measure by jump height. An increase in jump height is expected.
Time Frame
Week 1
Title
Jumping test
Description
Measure by jump height. An increase in jump height is expected.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a confirmed diagnosis of spastic cerebral palsy independent ambulatory able to follow verbal instructions willing to commit to participate for the full study Exclusion Criteria: had previous orthopedic surgery or botulinum toxin A injection in the lower limb within past 6 months had a structured lower limb exercise training within the past 6 months plan to go for any structured outside-of the-study exercise training had any heart, lung, vision, hearing or bodily issues that can interfere with participation and completion of the study had any other diseases that interfere with physical activity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harshvardhan Singh, PhD
Phone
205-996-1413
Email
hsingh@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Phuong Quach, MPH
Phone
205-774-8448
Email
phuong@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harshvardhan Singh
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HARSHVARDHAN SINGH
Phone
205-996-1413
Email
hsingh@uab.edu
First Name & Middle Initial & Last Name & Degree
HARSHVARDHAN SINGH, BPT, MS, PHD
First Name & Middle Initial & Last Name & Degree
Phuong Quach, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy

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